It is estimated that 35 million Americans experience some degree of alopecia, or hair loss, resulting in 900 million dollars a year being spent in efforts to grow it back. Generally, it affects about 30 million men and 20 million women in the U.S. each year. It is believed that baldness is hereditary and occurs when the hair follicles slowly begin to produce finer and shorter hairs, or stop producing hairs at all. There are many forms of hair loss, ranging from alopecia areata to androgenic alopecia, also known as male or female pattern baldness.
Around 40% of men will have some hair loss by their mid 30's, and nearly 60% of women experience some thinning of the hair after menopause. By age 50, half of all males generally experience hair loss patterns as compared to 50-70% of post-menopausal women. Alopecia becomes more common as age increases, but hair loss may start at younger ages. Without drug therapy or cosmetic treatments, alopecia can remain as a permanent condition.
In addition, animals can also suffer from a variety of dermatologic conditions. Such conditions frequently cause stress to the animal's haircoat resulting in hair loss, which further exacerbates an increased health risk to the animal and increased concern to the pet owner. Common examples of dermatologic conditions of animals, which can result in hair loss, include sebaceous adenitis, primary seborrhea, primary idiopathic seborrhea, seasonal alopecia, and other miscellaneous dermatoses.
To treat human alopecia, the prior art has produced an enormous variety of drug and cosmetic treatments. The reason for such a volume of treatment options stems from the difficulty the medical and scientific community have had in establishing the cause of alopecia. Alopecia has many possible causes, such as genetic disorders, infections, contact with toxic agents, and hormone imbalance. Currently, there are only two drugs approved by the Food and Drug Administration to treat alopecia.
Rogaine®, also known as minoxidil, was originally developed as a treatment for individuals with high blood pressure. While treating those individuals, it was discovered that minoxidil also moderately increased hair growth and prevented future hair loss. It is believed that minoxidil may increase hair growth in thinning hair areas. However, there are problems associated with the use of minoxidil. The most common problems are irritation of the skin, and if the medication is stopped after prolonged use, hair loss may actually increase rather than decrease. Further, major complications of minoxidil are rare, but possible, and patients who suffer from heart disease or hypertension cannot utilize this product without medical supervision.
The other approved product to treat alopecia is Propecia®, or finasteride. Propecia® originally was used to treat prostate enlargement by inhibiting the 5-alpha reductase enzyme. Men undergoing that treatment experienced an increase in hair growth while receiving finasteride. It is believed that the inhibition of the 5-alpha reductase enzyme may increase hair follicle growth or prevent future hair follicle loss. However, pregnant or nursing women may not use finasteride because the product is teratogenic, and can harm the human fetus. Due to such a serious health risk, Propecia® has been limited to use within male patient populations only, leaving a majority of female alopecia sufferers to seek alternative treatment options.
Because of the downfalls of currently approved drug therapies for the treatment and prevention of human alopecia conditions, cosmetic treatments have been developed as well. One cosmetic treatment, as noted within U.S. Pat. No. 4,999,187 to Vernon, discloses a hair and scalp treatment composition that comprises 60% by weight or more of petrolatum in combination with 5% by weight or more sulfur, 0.5% by weight or more of 1,2,3-propanetriol, and the remaining 0.5 to 10% of the composition comprised of an oil, such as coconut oil. The composition is said to treat the hair and scalp to effectively prevent dandruff in the hair while conditioning and causing the hair to grow in areas of the scalp where it had previously ceased to grow. However, the '187 patent does not disclose the use of its composition for a variety of alopecia conditions such as alopecia areata. Rather, the '187 patent merely addresses the conditioning of the hair and scalp.
Another cosmetic treatment involves implanting synthetic or artificial hair into hair follicle root bulbs of the scalp, or implanting expandable balloon structures under the scalp, to stimulate natural hair growth. However, it has been found that artificial hair implant methods are almost always unsuccessful. Such implants often become infected, leading to increased patient health risk and further natural hair follicle loss. In response to the failure of artificial hair transplants, other implant treatments utilizing human hair have been developed. Of human transplants available, four invasive surgical methods are currently preferred within the medical community.
The first of those surgical methods includes hair grafts, in which a graft of a small area of hair bearing scalp is moved from one area of the head to another. Alopecia or bald areas are replaced with hair bearing scalp tissue grafts to allow for development of new, natural hair in the transplanted area. However, when such a graft is moved from one area of the scalp to another area, it loses its blood supply, and must reestablish a new one. If a new blood supply cannot be reestablished upon placement of the graft or if infection occurs, this surgical method will fail, resulting in no new hair growth, only scarred tissue.
An alternative surgical method is the hair flap, in which a piece of scalp along with its blood supply is moved from one location on the head to another. This method generally is used only when large areas of hair bearing scalp need to be moved, and the procedure involves a lengthy recovery time. For those seeking a less invasive and shorter recovery time, excision or scalp reduction has been developed. Excision or scalp reduction involves removing the hairless scalp tissue areas and stretching the remaining non-hairless scalp to cover the defect. Here again, the patient is subjected to a surgical procedure with its inherent risks and complications.
The last cosmetic surgical treatment method for hair loss involves tissue expansion, in which small balloons are placed beneath the hair bearing scalp, and the balloons are then expanded slowly over several weeks to stretch the adjacent area of the scalp intended to be used to cover the defect. This method again, has surgical risks and complications including scarring, as well as a lengthier treatment and recovery period due to the length of time needed to stretch the existing scalp tissue and for the incisions to heal.
Although surgical cosmetic treatments for alopecia are available, many problems exist with such treatment options. The main problems specifically associated with all of these methods are the need for multiple operations, scarring when the scalp is moved or stretched, unexpected results, and development of numbness in the scalp following the surgical procedure. Further, the patient is subjected to the risks of surgery in general, as well as swelling, bruising, bleeding, and infection during the recovery process.
More than 40 U.S. and several hundred foreign patents have been issued for hair loss/alopecia treatment methods and compositions. Yet, no single agent or method of treatment has been found to universally work against all forms of hair loss. Thus, the treatment process is often one of trial and error, leaving the patient searching for the treatment that will produce the desired result for them.
There is a need in the prior art for a composition and method of treatment regimen for the treatment and prevention of a variety of human alopecia conditions that are non-invasive, can be used in male and female treatment populations without reproductive risk, and can prevent future hair follicle loss while stimulating new hair follicle growth. In addition, there is a need within the prior art for a composition and method of treatment regimen for the treatment and prevention of a variety of animal alopecia conditions to maintain and stimulate a healthy haircoat upon the animal's skin.